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Director, Clinical Sciences
4 months ago
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Description
Lyra Therapeutics (Nasdaq: LYRA) is a late clinical stage company developing medicines precisely designed to target ear, nose, and throat (ENT) diseases. Our goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and new treatment options for their patients. Our initial product candidates, LYR-210 and LYR-220, are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and intended to deliver up to six months of continuous drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis, or CRS. Headquartered in the Boston area, Lyra Therapeutics was foundedby George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science, and biotechnology.
Lyra Therapeutics is growing, and we are seeking a highly skilled and experienced Director/Sr. Director of Clinical Sciences, to join our dynamic Clinical Development team. Reporting to the Senior Vice President, Clinical Affairs, the Director of Clinical Sciences will play a crucial role in driving scientific, clinical, and operational strategy to late stage clinical development. This role will lead cross-functional study teams for the study design, data interpretation, and communication. The successful candidate will have a strong background in clinical research, a deep understanding of regulatory requirements, and the ability to lead cross-functional teams.
Responsibilities
* Develop and implement the clinical development strategy for Lyra's products
* Work closely with the Clinical executive team to align clinical programs with overall business objectives
* Design and oversee the execution of clinical trials, ensuring compliance with regulatory standards and guidelines
* Work with a cross-functional team to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities
* Manage a Clinical Scientist
* Foster collaboration and communication among internal and external team members to drive successful clinical development milestones
* Provide scientific and medical expertise to guide clinical development programs
* Work closely with medical monitors and key opinion leaders to ensure the scientific integrity of clinical trials
* Support Clinical Operations function with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs
* Provide analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
* Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety
* Provide support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports
* Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents
* Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations
* Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors
* Prepare literature reviews
* Support preparation of scientific material for conference presentations and publications
* Manage the budget for clinical development activities
* Optimize the allocation of resources to meet project timelines and goals
Requirements
* Advanced degree in life sciences (MD, PhD, or equivalent) with at least 10 years of clinical research experience in the pharmaceutical industry
* Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; global clinical research experience and experience working with clinical trial sites preferred
* Excellent oral and written communication skills and solid analytical skills
* Ability to work collaboratively in a fast-paced, team-based matrix environment
* Exceptional organizational and project management skills with the ability to handle multiple projects at a time
* Ability to lead and motivate cross-functional teams
* Strategic mindset with the ability to align clinical development with business goals while being detail oriented
* Ability to think creatively and innovatively with flexibility to accommodate changes in team and project needs
* Experience in all stages of drug development preferred
At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit cover letter and CV.
